Index to FDA Warning Letters (2001)

Stephen Barrett, M.D.

The Federal Food, Drug, and Cosmetic Act (FDC Act) defines
"drug" as any article (except devices) "intended
for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease" and "articles (other than food) intended
to affect the structure or function of the body." All drugs
and devices must be labeled with adequate directions for
all intended uses. Labeling includes any written, printed
or graphic material that accompanies a product. Intended use
is determined by the facts at hand. Products not generally
recognized as safe and effective by experts are considered
"new." Improper labeling is called misbranding.
Marketing a "new" or misbranded drug or device in interstate
commerce is a federal crime. Marketing without adequate directions
for use is also a federal crime.

When products are marketed improperly, the FDA may issue a
warning letter specifying the violations and demanding
to know how the problem will be corrected. If a warning is ignored,
or if the FDA decides to begin with more forceful action, the
agency can initiate court proceedings for a seizure, injunction,
or criminal prosecution. Marketers of legitimate products usually
correct the problems immediately. Marketers of quack products
vary. Some comply, but many stall, attempt to obfuscate, and/or
continue to do as much as they think they can get away with.

Warning letters
issued since November 1996 are posted to a database on the
FDA's web site that enables searches by company, subject, issuing
office, date, and text content. Quackwatch plans to list most
of the actions related to foods, dietary supplements, herbs,
homeopathic remedies, and devices marketed with misleading health
claims. The letters issued in 2001 are summarized below in reverse
chronological order

Jean's
Greens, Norway, N.Y. (11/28/02). Warning to owner
Jean Argus that it was illegal to claim that Forticel (brewed
tea) and Forticel Mix is effective against cancers; ulcer
and kidney disorders; digestive and intestinal problems; headaches;
and crhonic and degenerative conditions.

ScienceBased
Health, Corte Madera, Calif. (11/9/01). Warning
to company CEO R. Scott Hunter that it was illegal to claim that
MaculaRx and MaculaRx Plus were designed to address age-related
degenerative conditions of the human eye and "may help reverse
symptoms of macular degeneration and eye disorders."

Institute
of Integrative Health, Knoxville, Tenn. (10/26/01). Warning
to Dr. Dennis Jones that Colostrex, Colostrex-D,Echibiotic, COQ10SODase,Thistlex, Tagmatol,
Marshmallow Herbal Cough Syrup,Lymphogen, and St.
Easewort were being marketed with illegal statements or suggestions
that they are useful against a large number of diseases and conditions.

Kabco,
Inc., Amityville, N.Y. (9/26/01). Warning to company
president Saiful Kinria that his company's cholesterol Support
Capsules could not be marketed as a dietary supplement. The
product, made from red yeast rice powder, contained a significant
amount of lovastatin (the active ingredient in the cholesterol-lowering
prescription drug Mevacor). For that reason, the letter stated,
marketing is illegal without FDA approval as a drug.

Ovimmune,
Columbus, Ohio (7/24/01). Warning to company president
Marilyn A. Coleman, PhD, that it is illegal to market eggs containing
antibodies produced by immunization of chickens with investigational
vaccines. The letter objected to claims on the company's web site
that the eggs can replace the immunity lost during AIDS, transplants,
burn, and cancer; ameliorate the effects of routine infections;
and "potentially treat all known diseases."

Rich
Nature Neutraceutical Laboratories, Lynnwood, Wash. (6/20/01)Warning to company president Richard J. Zhang that the company's
CholesCare could not be marketed as a dietary supplement.
The product, made from red yeast rice powder, contained a significant
amount of lovastatin (the active ingredient in the cholesterol-lowering
prescription drug Mevacor). For that reason, the letter stated,
marketing is illegal without FDA approval as a drug.

Neutraceutical
International Corporation, Park City, Utah (6/19/01).
Warning to company chairman and CEO Frank W. Gay that the
company's KAL cholesterol Defense, Soloray Red Yeast
Rice, and Soloway Guggul & Red Yeast Rice could
not be marketed as dietary supplements because they contained
a significant amount of lovastatin (the active ingredient in the
cholesterol-lowering prescription drug Mevacor). For that reason,
the letter stated, marketing is illegal without FDA approval as
a drug.

Nature's
Sunshine Products, Provo, Utah (6/19/01). Warning
to company president and CEO Daniel Howells that the company's
Cholest-Reg could not be marketed as a dietary supplement
because they contained a significant amount of lovastatin (the
active ingredient in the cholesterol-lowering prescription drug
Mevacor). For that reason, the letter stated, marketing is illegal
without FDA approval as a drug.

Good
for You America, Syracuse, N.Y. (6/7/01). Warning
to company owner Craig E. Sallin that it was illegal to claim
that its prodict Maca Manna would provide hormonal balance
and rejuvenation, and protect against various infections, and
was useful against male impotence, infertility disorders, osteoporisis,
memory disorders, prostatitis, and seberal other problems.

Natural
Health Consultants, Vallejo, Calif (6/7/01). Warning
to Gerald T. Wolke, R.Ph. that the Bioscan 2010, a device
purported to determine the likelihood of developing a serious
disease, is unregistered and unapproved and therefore illegal
to sell in the United States.

OraLabs,
Inc., Engelwood, Calif. (6/4/01). Warning to company
president and CEO Gary H. Schlatter that the company's Cholesterx
could not be marketed as a dietary supplement. The product, made
from red yeast rice powder, contained a significant amount of
lovastatin (the active ingredient in the cholesterol-lowering
prescription drug Mevacor). For that reason, the letter stated,
marketing is illegal without FDA approval as a drug.

Barlean's
Organic Oils, Ferndale, Wash. (6/4/01). Warning
to company president Bruce D. Barlean that 23 flax oil, borage
oil and other organic seed oil products were being marketed with
illegal claims that they are effective against various serious
diseases. The illegal claims were made on the company's Web site,
in it's "Product Selection Guide, and in various reprints
and other reports that the FDA consodered to be labeling.

Maypro
Industries, Purchase, N.Y. (5/8/01). Warning to
company president Steve Yamada that the company's bulk red
yeast rice powder could not be marketed as a dietary supplement
because it contained a significant amount of lovastatin (the active
ingredient in the cholesterol-lowering prescription drug Mevacor).
For that reason, the letter stated, marketing is illegal without
FDA approval as a drug.

Norbec,
Rancho Murieta, Calif. (4/3/01). Warning to company
president Michael King that its Noiseless Antisnoring mouth
guard was an unapproved medical device that was illegal to
makret in the United States without FDA clearance.

Nutrition
Dynamics, Seguin, Texas, (3/12/01). Warning to
company president Winston G. Morrow, D.C., that the company was
making illegal claims that Valerian Root, Chinese Garlic,
Coenzyme Q10, Optimum Health Essentials, and Nux
Vomica Homaccord could prevent and/or treat against long lists
of diseases and conditions.

Vitamin
Classics, Calabasas, Calif. (2/21/01). Warning
to company CEO Greg Rubin that two Burn That Fat fruit drinks
were being marketed with the illegal claim that they were "
formulated from a select blend of herbs and chromium picolinate
to lower cholesterol."

Ocean
Spray Cranberries, Lakevill-Middleboro, Mass. (1/19/01).
Warning to company president Robert Hawthorne that its grapefruit
juice products were being marketed with unauthorized claims that
vitamin C is "associated with a reduced risk of chronic diseases
such as cancer, cardiovascular disease and cataracts." The
letter also noted that certain Web site claims "not only
overstate any possible benefit associated with grapefruit juice
consumption but also understate the very real risks associated
with concomitant use of certain drugs and grapefruit juice."

Age
Less Products, Albemarle, N.C. (1/16/01). Warning
to company president P. Wayne Morris that its Curetage System
was being marketed with illlegal claims that it "promotes
the growth of thick healthy hair" and that "It's the
'CURE' Not Just The Prevention" of thinning hair.